Data / Medical devices / Turkey / Ivus Ilac Sanayi Ve Ticaret AS
Ivus Ilac Sanayi Ve Ticaret AS: FDA-registered device maker in Istanbul, Turkey, 86 510(k) clearances and 1 PMA approval
Ivus Ilac Sanayi Ve Ticaret AS is registered with the FDA (registration 3021632375) in Istanbul, Turkey. It lists 51 device types. The FDA files 86 510(k) clearances and 1 PMA approval under its listings, the newest dated January 23, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021632375
- Address
- Yesilkoy cad. No 25 Florya Bakirkoy, Istanbul, Turkey, 34153
- Owner or operator
- IVUS ILAC SANAYI VE TICARET AS (10084070)
- Roles
- Exporter to the US
- First device listed
- January 14, 2022
- Registered through
- 2026
- Brand names listed
- B, BXT, CVT, MD, MSM, P, PED, STR and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2023 | K223158 | LigaSure XP Maryland Jaw Sealer/Divider | GEI | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| September 30, 2022 | K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 27, 2022 | K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| April 1, 2022 | K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | KDI | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| November 29, 2021 | K210930 | ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| May 24, 2021 | K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia | LPL | Substantially Equivalent | Bausch & Lomb, Incorporated | accessdata.fda.gov |
| December 18, 2020 | K202006 | ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System | GEI | Substantially Equivalent | ArthroCare Corporation | accessdata.fda.gov |
| November 2, 2020 | K202552 | Midas Rex Attachments and Dissecting Tools | OLO | Substantially Equivalent | Medtronic Powered Surgical Solutions (Mpss) | accessdata.fda.gov |
| December 6, 2019 | K192443 | Dextile Anatomical Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 23, 2018 | K180046 | Masimo Rad-97 and Accessories | DQA | Substantially Equivalent | Masimo Corporation | accessdata.fda.gov |
| April 10, 2018 | K180299 | ACUVUE OASYS (senofilcon A) with Photochromic Additive | LPL | Substantially Equivalent | Johnson & Johnson Vision Care, Inc. | accessdata.fda.gov |
| December 20, 2017 | K172565 | Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device | PWJ | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| October 27, 2017 | K171979 | Tubing Pack | DWF | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| September 7, 2017 | K170381 | Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini | GEI | Substantially Equivalent | Medtronic Advanced Energy | accessdata.fda.gov |
| July 7, 2017 | K171454 | Interject Injection Therapy Needle Catheter | FBK | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
| July 3, 2017 | K171267 | NavLock Trackers | OLO | Substantially Equivalent | Medtronic Navigation | accessdata.fda.gov |
| December 7, 2016 | K163034 | SUTUREFIX Curved Suture Anchor | MBI | Substantially Equivalent | Smith and Nephew, Inc. | accessdata.fda.gov |
| November 22, 2016 | K161763 | Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device | HIH | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 14, 2016 | K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 15, 2016 | K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated | GEI | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 26, 2016 | K160176 | Signia Stapler | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 1, 2016 | K160230 | VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm | GCJ | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 18, 2015 | K151356 | Spacemaker Pro Access and Dissector System | GCJ | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| March 13, 2015 | K143386 | Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 14, 2014 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 30, 2014 | K142869 | Premium Surgiclip III | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 28, 2014 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 17, 2014 | K141344 | EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM | FAD | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| July 21, 2014 | K140879 | BIOSURE HEALICOIL PK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| April 9, 2014 | K140609 | RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE WITH STANDARD PURCHASE ABSORBLE TACKS | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 22, 2014 | K133938 | ENDO GIA REINFORCED RELOAD WITH TRI-STAPLE TECHNOLOGY | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 13, 2013 | K132441 | BARD VENTRALEX HERNIA PATCH | FTL | Substantially Equivalent | C.R. Bard, Inc. | accessdata.fda.gov |
| December 3, 2013 | K132974 | AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR | GEI | Substantially Equivalent | Medtronic Advanced Energy, LLC | accessdata.fda.gov |
| October 30, 2013 | K132357 | SMITH & NEPHEW ULTRATAPE | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| March 14, 2013 | K130435 | VERSAPORT V2 BLADELESS OPTICAL TROCAR | GCJ | Substantially Equivalent | Covidien, Formerly US Surgical A Divison of Tyco H | accessdata.fda.gov |
| October 23, 2012 | K123109 | ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE | GDW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 18, 2012 | K121861 | SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| May 3, 2012 | K121194 | ENDO CLIP III 5MM CLIP APPLIER | FZP | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 20, 2012 | K113294 | SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR | MBI | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| November 5, 2010 | K101519 | PARIETEX PLUG AND PATCH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 5, 2010 | K101657 | RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 | KGE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| August 23, 2010 | K102082 | EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 | FGE | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| April 22, 2010 | K100959 | SPECIMEN RETRIEVAL SYSTEM | GCJ | Substantially Equivalent | Applied Medical Resources | accessdata.fda.gov |
| January 28, 2010 | K092508 | FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, | GAT | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| December 15, 2009 | K090785 | MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 | MWI | Substantially Equivalent | Invivo Corp. | accessdata.fda.gov |
| May 14, 2009 | K090470 | AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES | OCW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 10, 2009 | K083519 | AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS | GDW | Substantially Equivalent | Covidien Lp, Formerly Registered AS United States | accessdata.fda.gov |
| April 3, 2009 | K090352 | TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES | BTR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 30, 2009 | K083635 | SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW | MBI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| August 27, 2008 | K081275 | BOSTON SCIENTIFIC SURGICAL MESH | PAH | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| May 28, 2008 | K081050 | PARIETEX PROGRIP MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| February 1, 2008 | K080106 | SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE | DRX | Substantially Equivalent | Leonhard Lang GmbH | accessdata.fda.gov |
| September 18, 2007 | K072315 | MIDAS REX CURVED BUR | HBE | Substantially Equivalent | Medtronic Powered Surgical Solutions | accessdata.fda.gov |
| June 29, 2007 | K071066 | SPYCATCH STONE RETRIEVAL BASKET | LQR | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| October 23, 2006 | K062850 | AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS | GDW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| October 5, 2006 | K062779 | DEFOGGING HEATED ENDOSCOPE LENS PROTECTOR (DHELP); DEFOGGING ENDOSCOPE LENS PROTECTOR (DELP) | GCJ | Substantially Equivalent | New Wave Surgical Corporation | accessdata.fda.gov |
| August 1, 2006 | K061373 | VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100 | GEI | Substantially Equivalent | Vnus Medical Technologies, Inc. | accessdata.fda.gov |
| June 16, 2005 | K051416 | SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA | JOH | Substantially Equivalent | Mallinckrodt Medical | accessdata.fda.gov |
| February 4, 2005 | K041892 | ZOLL AED PRO EXTERNAL DEFIBRILLATOR | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| January 6, 2005 | K042938 | GAMBRO PRISMAFLEX HF1000 AND HF1400 SETS | KDI | Substantially Equivalent | Gambro Renal Products | accessdata.fda.gov |
| September 24, 2004 | K042412 | MODIFIED SPACEMAKER SYSTEM | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| July 12, 2004 | K041413 | XPS 3000 SYSTEM | ERL | Substantially Equivalent | Medtronic Xomed, Inc. | accessdata.fda.gov |
| May 21, 2004 | K033474 | ZOLL AED PLUS | MKJ | Substantially Equivalent | Zoll Medical Corp | accessdata.fda.gov |
| February 20, 2004 | K032979 | PHILIPS SPO2 REUSABLE SENSORS, MODEL NOS. M1191T, M1192T, AND M1193T | DQA | Substantially Equivalent | Philips Medical Systems, Inc. | accessdata.fda.gov |
| August 8, 2003 | K032224 | BIORCI SCREW | HWC | Substantially Equivalent | Smith & Nephew, Inc. | accessdata.fda.gov |
| September 25, 2002 | K022100 | NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010 | HAW | Substantially Equivalent | Image-Guided Neurologics, Inc. | accessdata.fda.gov |
| March 18, 2002 | K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM | HBB | Substantially Equivalent | Medtronic Midas Rex | accessdata.fda.gov |
| September 6, 2001 | K012539 | VERASTEP | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 19, 2001 | K010052 | RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER | MQM | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 9, 1998 | K981579 | ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG | MDM | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| October 9, 1997 | K971320 | CRE BALLOON DILATATION CATHETER | KNQ | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| November 4, 1996 | K963901 | ELECTROSURGICAL PROBE | GEI | Substantially Equivalent | Smith & Nephew Endoscopy, Inc. | accessdata.fda.gov |
| January 30, 1996 | K954483 | STRYKER SAGITTAL SAW ATTACHMENT | GFA | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| May 3, 1995 | K951589 | MANUAL SURGICAL INSRUMENT | GEI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 16, 1994 | K934738 | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE | OCW | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| January 31, 1994 | K935762 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| February 1, 1993 | K922123 | AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH | GCI | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| September 17, 1992 | K920068 | AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR | GCJ | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| May 29, 1992 | K915526 | COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH | FTL | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| March 6, 1991 | K904233 | CONVATEC ABSORBENT BANDAGE | EXE | Substantially Equivalent | Convatec, A Division of E.R. Squibb & Sons | accessdata.fda.gov |
| November 20, 1987 | K873964 | NICOLET DISPOSABLE PRASS PROBE | ETN | Substantially Equivalent | Nicolet Biomedical Instruments | accessdata.fda.gov |
| October 2, 1986 | K863330 | DISPOSABLE PNEUMOPERITONEUM NEEDLE | FHO | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc | accessdata.fda.gov |
| June 16, 1983 | K830719 | UNIVERSAL CANNULA | GCJ | Substantially Equivalent | Acufex Microsurgical, Inc. | accessdata.fda.gov |
| June 26, 1981 | K811447 | SHILEY DISPOSABLE CANNULA TRACH. TUBE | BTO | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 28, 1993 | P900056 | ROTABLATOR(R) | MCX | 219 | October 21, 2026 | accessdata.fda.gov |
Compare with other makers
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Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.